Published Phase III Study Shows Striant is a Safe and Effective Treatment Option for Hypogonadal Men.

LIVINGSTON, N.J. -- Researchers Report That Novel Buccal Delivery System Consistently Maintains Testosterone Concentrations and Requires No Dose Adjustment

Columbia Laboratories, Inc. (NASDAQ:CBRX) announced today that results of a Phase III study demonstrate that Striant(R) (testosterone buccal system) (CIII) 30 mg is a safe and effective treatment for testosterone replacement in hypogonadal men when applied twice daily, with no dose adjustment required. Study results appear in this month's issue of the Journal of Clinical Endocrinology and Metabolism.

Hypogonadism, a condition associated with a deficiency or absence of endogenous testosterone, affects nearly five million American men. The published study results provided the basis for the U.S. Food and Drug Administration (FDA) approval of Striant, which utilizes Columbia's patented progressive hydration buccal technology to deliver testosterone via the buccal cavity (inside the mouth) twice daily. Striant is the first commercially available product to use buccal delivery; Columbia is investigating additional product candidates using this novel delivery system.

"This study demonstrates that the buccal delivery system consistently maintains testosterone levels within the normal range without dose adjustment, and with minimal local reactions," said Christina Wang, MD, Professor of Medicine, Endocrinology Division, Harbor-UCLA Medical Center and lead study investigator. "As a result, we can conclude that Striant is a reliable alternative to currently available methods for physiologic testosterone replacement in hypogonadal men."

Nine centers enrolled 98 hypogonadal men (aged 20-75 years) into a 12-week, multicenter, single-arm, open-label study. The 82 patients who completed the study protocol were treated with Striant (30 mg) twice daily for the trial period. Serum testosterone and dihydrotestosterone (DHT) were measured throughout the course of the study as well as multiple times over a 24-hour period during the last day of therapy.

In the trial, 86.6 percent of patients had an average testosterone concentration within the physiologic range (3.0 to 10.5 ng/ml) at the end of 12 weeks, and average serum testosterone concentration over the 24-hour dosing period was 5.4 ng/ml.

The average percent of time in the last 24 hour dosing interval that serum testosterone concentrations were above the lower limit of the adult male range was 80.1 percent. Mean DHT concentrations remained in the normal range throughout the course of the study as well as the last 24 hour dosing interval.

A total of 16 patients reported 19 gum-related adverse events, including edema, gingivitis, inflammation and blisters. These adverse events were transient, mild or moderate in intensity, generally did not cause interruption of treatments, and resolved completely within a short period of time. Gum irritation was reported by 8 subjects and bitter taste by 3 subjects. All other treatment-related adverse events occurred in two or fewer subjects.

"Results of this latest study further support previously published data, and show Striant maintains average serum testosterone levels and DHT concentrations within the normal range," said George W. Creasy, M.D., vice president of clinical research at Columbia Laboratories. "For the treatment of hypogonadism, Striant offers physicians and their patients a unique buccal delivery system that delivers consistent blood levels of the hormone without titration."

About Hypogonadism

Hypogonadism (low testosterone) can be caused by conditions associated with the testes, pituitary gland, hypothalamus gland, or by a genetic disorder. Signs and symptoms of hypogonadism can include decreased sexual desire, erectile dysfunction (ED), fatigue, depression, reduced muscle mass, and osteoporosis. Testosterone replacement therapy helps to provide and maintain normal levels of testosterone.

About Striant

Prior to the introduction of Striant, patients with hypogonadism have been treated with transdermal patches, topical gels, injectable formulations of testosterone or surgically-inserted testosterone implants. The controlled- and sustained-release buccal testosterone product (which has the appearance of a small monoconvex tablet) acts by adhering to the buccal mucosa; the small, natural depression in the mouth where the gum meets the upper lip above the incisor teeth. As it is exposed to saliva the product softens and molds to the shape of the gum, where it remains comfortably in place over each 12-hour dosing period. The product delivers testosterone through the buccal mucosa, where it is absorbed into the bloodstream and delivered directly into the superior vena cava (major blood vessel), bypassing the gastrointestinal system and liver. Striant is able to produce circulating testosterone concentrations in hypogonadal males that approximate physiologic levels seen in healthy young men. Striant is available in a single strength, and no dose titration is required.

On June 19, 2003, the U.S. Food and Drug Administration (FDA) approved Striant(R) (testosterone buccal system) mucoadhesive (CIII), the first-ever transbuccal treatment for testosterone replacement therapy in men for conditions associated with a deficiency or absence of endogenous testosterone, including hypogonadism. The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) approved Striant(TM) SR 30 mg Mucoadhesive Buccal Tablets for testosterone replacement therapy in men with primary or secondary hypogonadism on February 27, 2004.

Important Safety Information

In the U.S. pivotal trial involving 98 patients, the most frequent adverse events that occurred with an incidence of one percent or greater which were possibly, probably, or definitely related to the use of Striant were: gum or mouth irritation (9.2%), bitter taste (4.1%), gum pain (3.1%), gum tenderness (3.1%), headache (3.1%), gum edema (2.0%), and taste perversion (2.0%). A total of 16 patients reported 19 gum-related adverse events. Of these, 10 patients (10.2%) reported 12 events of mild intensity, 4 patients (4.1%) reported 5 events of moderate intensity, and 2 patients (2.0%) reported 2 events of severe intensity. Four patients (4.1%) discontinued treatment with Striant due to gum or mouth-related adverse events including 2 with severe gum irritation, 1 with mouth irritation, and 1 with "bad taste in mouth." The majority of the gum-related adverse events were transient and resolved within 1 to 14 days. Patients should be advised to regularly inspect the gum region where they apply Striant and report any abnormality to their health care professional.

Striant is not indicated for women and must not be used in women. Testosterone supplements may cause fetal harm. Striant should not be used in patients with known hypersensitivity to any of its ingredients including testosterone USP that is chemically synthesized from soy.

Androgens are contraindicated in men with carcinoma of the breast or known carcinoma of the prostate. Edema with or without congestive heart failure may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease. In addition to discontinuation of the drug, diuretic therapy may be required. Gynecomastia frequently develops and occasionally persists in patients being treated with androgens for hypogonadism. The treatment of hypogonadal men with testosterone esters may potentiate sleep apnea in some patients, especially those with risk factors such as obesity or chronic lung diseases. Geriatric patients treated with androgens may be at an increased risk for the development of prostatic hyperplasia and prostatic carcinoma. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, insulin requirements.

About Columbia Laboratories

Columbia Laboratories, Inc. is a U.S.-based international pharmaceutical company dedicated to the development and commercialization of women's health care and endocrinology products, including those intended to treat infertility, dysmenorrhea, endometriosis and hormonal deficiencies and to reduce the risk of pre-term labor. Columbia markets Striant(R) (testosterone buccal system) for treatment of hypogonadism in men, Prochieve(R) 8% (progesterone gel) for progesterone supplementation as part of an Assisted Reproductive Technology treatment for infertile women with progesterone deficiency, and Prochieve(R) 4% (progesterone gel) for the treatment of secondary amenorrhea. Columbia has developed a buccal delivery system for peptides. Columbia's products primarily utilize the company's Bioadhesive Delivery System technology. For more information, please visit www.columbialabs.com.

This press release contains statements that constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Those statements include statements regarding the intent, belief or current expectations of the company and its management team. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those projected in the forward-looking statements. Such risks and uncertainties include, among other things, the successful marketing of Striant(R), Prochieve(R) 8% and Prochieve(R) 4%; the impact of competitive products and pricing; the timely and successful development of products; timely and successful completion of clinical studies; success in obtaining acceptance and approval of new products by FDA and international regulatory agencies; competitive economic and regulatory factors in the pharmaceutical and healthcare industry; general economic conditions; and, other risks and uncertainties that may be detailed, from time-to-time, in Columbia's reports filed with the Securities and Exchange Commission. The company undertakes no obligation to publicly update any forward-looking statements.

Striant(R) and Prochieve(R) are registered trademarks and Striant(TM) SR is a trademark of Columbia Laboratories, Inc.

Please refer to full prescribing information for additional information.